Clinical Precision

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government has passed new regulations and is establishing clinical practice centres to train investigators and staff.

Still, China has its drawbacks. Bureaucracy and strict government regulations pose ongoing risks for companies. For example, gaining approval from the Chinese State Food and Drug Administration (SFDA) to conduct a trial can take 9 to 12 months, and companies must acquire a drug import license for every shipment that enters the country, rather than one for each type of drug.

On the downside, IP protection in India has been weak and the country does not permit foreign companies to conduct phase I clinical trials. There are some bureaucratic headaches as well. It is mandatory for pharmaceutical companies to coordinate their efforts with local physicians and local hospitals and to perform toxicology tests between phases II and III, which can cause delays.

The silver lining is that the regulatory mechanism relating to clinical trials is being further strengthened and this in turn will boost the number of trials being conducted here. The setting of institutional review boards or ethics committees are all steps in this direction, says Utkarsh Palnitkar, head of life sciences practice, Ernst & Young India.

Then, the introduction of clinical trials registry by the Indian Council of Medical Research (ICMR) will help in creating a database for future use for meta-analysis of studies conducted in a therapeutic area of concern. It will also help in developing national guidelines for managing health care based on evidence-based medicine, says Reddy of Vimta Labs. “Whichever country does that will attract sponsors as it will lead to competition in excellence, rather than in volumes and value. Operational timelines should be transparent in the regulatory decision making bodies as this can move us faster, as time is the essence for cost control,” he adds.

An important issue pertains to the acute shortage of manpower. McKinsey projects that within five years, 1,500 to 2,000 GCP studies will be conducted in India per year, requiring 10,000 to 15,000 GCP-trained investigators, and supported by 50,000 clinical research professionals. At the moment, India is short by 30,000 to 50,000 research personnel, including trial investigators, auditors, and personnel to serve on ethics committees and data safety management boards. However, India has substantial capacity to meet the rapidly growing demand for clinical trials. It has 300 universities, over 750 graduate and post-graduate programmes, and about 50 million college graduates.